{"id":20247,"date":"2020-11-25T12:41:21","date_gmt":"2020-11-25T07:11:21","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=20247"},"modified":"2024-11-19T10:29:23","modified_gmt":"2024-11-19T04:59:23","slug":"abuse-of-patent-right-with-respect-to-drugs","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/abuse-of-patent-right-with-respect-to-drugs\/","title":{"rendered":"Lets Understand the Abuse of Patent Right with respect to Drugs"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Patent right is not an absolute\nmonopoly right with respect to manufacturing of drugs. It is a confined right\nand is subject to specific approved limitations. The Patent Act balances the individual\nright of patentee &amp; interest of common public. The main purpose of Patent Act\nis to encourage the development of technology as well as innovation.<\/p>\n\n\n\n<p>The Patent Act offers protection to an inventor for their invention providing them with exclusive right and protection from infringement or any illegal use of that invention by any other person. The government grants the exclusive rights to the Patentee after <a href=\"https:\/\/corpbiz.io\/patent-registration\"><strong>Patent Registration<\/strong><\/a>.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/abuse-of-patent-right-with-respect-to-drugs\/#What_are_the_Rights_of_Patentees_According_to_Patent_Act\" >What are the Rights of Patentees According to\nPatent Act?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/abuse-of-patent-right-with-respect-to-drugs\/#When_Patent_Rights_are_not_getting_Infringed\" >When Patent Rights are not getting Infringed?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/abuse-of-patent-right-with-respect-to-drugs\/#General_Principles_Applicable_to_working_of_Patented_Inventions\" >General Principles Applicable to working of Patented Inventions<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/abuse-of-patent-right-with-respect-to-drugs\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Rights_of_Patentees_According_to_Patent_Act\"><\/span>What are the Rights of Patentees According to\nPatent Act?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Section 48\u00a0of the Patent Act<\/strong> talks about the rights granted to the patentee. The section confers the patentee with the exclusive right to prevent any third parties from creating, using, selling the product in India in case of product patent. <\/p>\n\n\n\n<p>Likewise, in case of process patent,\nthe patentee has exclusive right to prevent any third parties from using the\nprocess for sale of any patented product acquired directly by that process. Section\n47 provides specific conditions where exclusive rights of patentee are restricted\nby specific acts:<\/p>\n\n\n\n<ol>\n<li>Any\nproduct in respect of which the patent is granted can be imported or made by\nthe Government for its own use;<\/li>\n\n\n\n<li>Any\nprocess in respect of which the patent is granted can be used by the Government\nfor its own use;<\/li>\n\n\n\n<li>Any\nproduct or process in respect of which the patent is granted can be made or\nused by any person for the purpose of experiment or research;<\/li>\n\n\n\n<li>In\ncase of any drug patent, the medicine can be imported by the Government for the\npurpose of its own use or distribution in any hospital or medical institution retained\nby the Government <\/li>\n<\/ol>\n\n\n\n<p>It is to be noted that there are\nother specified act which does not amount to infringement of the patent right.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"When_Patent_Rights_are_not_getting_Infringed\"><\/span>When Patent Rights are not getting Infringed?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 49&nbsp;offers that patent\nrights are not get infringed when used on overseas vessels temporarily or\naccidentally. The use of the creation on vessel or aircraft listed in a foreign\ncountry or a land vehicle owned by a person who is a resident of other country\nwho comes to India temporarily or accidentally, will not infringe the Patentee\nrights. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Patent Provisions for the Interest of General Public <\/h3>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" width=\"1024\" height=\"341\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/11\/Patent-Provisions-for-the-Interest-of-General-Public-1024x341.png\" alt=\"Patent Provisions\" class=\"wp-image-20248\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/11\/Patent-Provisions-for-the-Interest-of-General-Public-1024x341.png 1024w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/11\/Patent-Provisions-for-the-Interest-of-General-Public-300x100.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/11\/Patent-Provisions-for-the-Interest-of-General-Public-768x256.png 768w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/11\/Patent-Provisions-for-the-Interest-of-General-Public.png 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n<h4 class=\"wp-block-heading\">Bolar-like provision &#8211; Manufacturing of Generic Drug<\/h4>\n\n\n\n<p>Various countries allow\nmanufacturing of generic drugs that utilizes the patented inventions for\ndevelopment of those generic Drugs. The details are required to be submitted\nunder the law. <\/p>\n\n\n\n<p>The generic Drugs producers can market\ntheir adaptation as soon as the patent of the original drug expires. This\nprovision is known as &#8220;Bolar-like provision&#8221; or &#8220;regulatory\nexception is provided under Patent Act under <strong><em>Section 107A (a)<\/em><\/strong>.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Parallel Import Provisions-Import of Patented\nProducts is not considered as Infringement<\/h4>\n\n\n\n<p>Parallel import provisions are explained\nin&nbsp;<strong><em>Section 107A (b)<\/em><\/strong>, that states the import of patented products\nby the Patentee and it will not be considered as an infringement of patent. So,\nit is likely to import any patented product from the licensee in any country\nwithout prior permission from the Patentee. The function of Parallel import is\nto ensure the abuse of patent rights and intended to manage the cost of\npatented products.<\/p>\n\n\n\n<p>Section 107A&nbsp;provides certain provisions\nthat state the conditions not to be considered as infringement of patent. <\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Working of Patented Invention<\/h4>\n\n\n\n<p>Government makes sure that no\npatent is exploited commercially in India and is available in the marketplace\nfor general public. Government ensures that there is no exploitation of patent\nrights. Patents are granted for the reason to encourage inventions that can improve\nthe industrial development and has to be worked in its full extent within\nIndia.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"General_Principles_Applicable_to_working_of_Patented_Inventions\"><\/span>General Principles Applicable to working of Patented Inventions <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 83&nbsp;of the Patent Act\nclearly states that the Patents are granted to encourage creation and to secure\nthat the creations is worked in India on profitable scale. It intends to see\nthat the patent right is not exploited by the patentee or any person obtaining\nthe title of patent. Patents are granted to take the advantages of the patented\ninvention available at affordable prices to the general public. Granted patent does\nnot prohibit Central Government in taking actions to protect the public health.<\/p>\n\n\n\n<p>For this purpose, government authorizes\nevery patentee to submit a statement regarding operation of the invention for\nevery year.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Statement Regarding Working of Patent<\/h3>\n\n\n\n<p>Every patentee and their assignee are\nrequired to submit a statement annually by the government to show the level in\nwhich the patented invention has been commercially utilized in India. If the\nstatement is not submitted within 3 months of the end of each year then the\npatentee is accountable for a penalty. Non-submission of such info yearly can\nlead to the grant of compulsory license on the patented invention.<\/p>\n\n\n\n<p>The details required to be\nsubmitted related to the use of invention is to show whether the discovery has\nbeen commercially exploited or not. If it is not utilized then the reason\nbehind its non utilization and the steps taken for its utilization are required\nto be submitted. If it is utilized then the information related to the capacity\nand worth of the patented product manufactured in India and imported from other\ncountries are to be furnished. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Compulsory Licenses<\/h3>\n\n\n\n<p>Compulsory licenses are accessible\nas a remedy against abuse of patent rights in India. The uses of Compulsory\nLicense are as follows-<\/p>\n\n\n\n<ol>\n<li>The provisions for compulsory licenses are made\nto prevent the exploitation of patent as a monopoly and to stop the commercial misuse.<\/li>\n\n\n\n<li>If any patented invention is not utilized then\nthere occurs possibility of grant of compulsory licenses by controller of the\npatent on the supposed patent.<\/li>\n<\/ol>\n\n\n\n<p>Any person concerned can file an application to the controller for grant of compulsory license on any of the following grounds-<\/p>\n\n\n\n<ul>\n<li>Reasonable requirements of the public regarding\nthe patented invention not being satisfied;<\/li>\n\n\n\n<li>The patented invention is not available to the\npublic at reasonable price;<\/li>\n\n\n\n<li>The patented invention is not utilized in India.<\/li>\n<\/ul>\n\n\n\n<p>However, in the occurrence of National Emergency or any intense urgency or public non-commercial utilization including public health crisis such as any epidemics to avoid any delay in the process provisions under Section 87 will not be applicable. The compulsory license can be approved immediately under Section 92 (3) with certain terms and conditions that the products manufactured under the patent should be available to the public at the lowest and affordable prices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A patent owner has the right to decide who can use the patented invention for the period for which the invention is safeguarded. After obtaining <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drug License<\/strong><\/a> with respect to Drug Patents, the protection of generic drugs is given to the patent owner. In other terms, patent protection states that the invention cannot be commercially made, utilized distributed, imported or put on sale by others without consent of owner of the patent. By doing the above mentioned you violate the Patent Right of the owner. Contact our professionals at <a href=\"https:\/\/corpbiz.io\/\"><strong>Corpbiz<\/strong><\/a> for the ease of filing of Patent Application.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/abolishing-of-drug-patents-a-boon-or-a-ban\/\">\nAbolishing of Drug Patents: A Boon or a Ban?\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Patent right is not an absolute monopoly right with respect to manufacturing of drugs. It is a confined right and is subject to specific approved limitations. The Patent Act balances the individual right of patentee &amp; interest of common public. The main purpose of Patent Act is to encourage the development of technology as well [&hellip;]<\/p>\n","protected":false},"author":18,"featured_media":20252,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[282],"tags":[1247],"acf":{"service_id":"20"},"authorName":"Sakshi Srivastava","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/03\/IMG-20180130-WA0007.jpg","authorDescription":"Sakshi has pursued B.B.A.LL.B.(IPR Hons.). She is an avid reader and is keen to gather and share her knowledge on the subjects relating to IPR, Company Law and GST. Priorly she has worked as a legal researcher and vide her articles she aims at improving the core knowledge of the subjects to the masses.","postViews":3420,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/20247"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/18"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=20247"}],"version-history":[{"count":21,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/20247\/revisions"}],"predecessor-version":[{"id":67206,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/20247\/revisions\/67206"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/20252"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=20247"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=20247"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=20247"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}